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Method for determining genotoxic substance 1, 2-dibromoethane of loratadine ring compound

A technology of loratadine and dibromoethane, which is applied in the field of analytical chemistry, can solve the problems of incomplete removal of genotoxic substances and affect the safety of medication, and achieve the effect of ensuring safety

Inactive Publication Date: 2021-03-23
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Incomplete removal of genotoxic substances in the loratadine ring compound will seriously affect the safety of the drug

Method used

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  • Method for determining genotoxic substance 1, 2-dibromoethane of loratadine ring compound
  • Method for determining genotoxic substance 1, 2-dibromoethane of loratadine ring compound
  • Method for determining genotoxic substance 1, 2-dibromoethane of loratadine ring compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Instruments and Conditions

[0039] Chromatograph: Agilent 6890N gas chromatograph;

[0040] Detector: electron capture detector;

[0041] Chromatographic column: 6% cyanopropyl-94% dimethylpolysiloxane capillary column;

[0042] Injection port temperature: 150°C;

[0043] Detector temperature: 250°C;

[0044] Carrier gas (nitrogen) flow rate: 3.0mL / min;

[0045] Split ratio: 10:1;

[0046] Injection volume: 1μL

[0047] Oven heating program:

[0048] Heating rate (℃ / min) temperature (°C) Hold time (min) / 100 0 8 120 5

[0049] Experimental procedure

[0050] Get 100mg of loratadine cyclic compound, dissolve it with solvent, be mixed with the need testing solution that every 1mL contains loratadine cyclic compound 100mg; Another get 1,2-dibromoethane appropriate amount, dissolve with solvent Dissolve it, and make it into a reference substance solution containing 0.0005 mg of 1,2-dibromoethane per 1 mL; take another 100 mg of lorata...

Embodiment 2

[0052] Instruments and Conditions

[0053] Chromatograph: Agilent 6890N gas chromatograph;

[0054] Detector: electron capture detector;

[0055] Chromatographic column: 6% cyanopropyl-94% dimethylpolysiloxane capillary column;

[0056] Inlet temperature: 170°C;

[0057] Detector temperature: 250°C;

[0058] Carrier gas (nitrogen) flow rate: 2mL / min;

[0059] Split ratio: 10:1;

[0060] Injection volume: 1μL

[0061] Oven heating program:

[0062] Heating rate (℃ / min) temperature (°C) Hold time (min) / 100 0 8 120 5

[0063] Experimental procedure

[0064] Take an appropriate amount of 1,2-dibromoethane, dissolve it in a solvent, and prepare a reference solution containing 0.0005 mg of 1,2-dibromoethane per 1 mL; take another 100 mg of loratadine ring compound, add 1.0 mL reference substance solution, prepared into a system suitability solution containing 100 mg of loratadine ring compound per 1 mL. Take the system suitability solution, ana...

Embodiment 3

[0066] Instruments and Conditions

[0067] Chromatograph: Agilent 6890N gas chromatograph;

[0068] Detector: electron capture detector;

[0069] Chromatographic column: 6% cyanopropyl-94% dimethylpolysiloxane capillary column;

[0070] Injection port temperature: 150°C;

[0071] Detector temperature: 250°C;

[0072] Carrier gas (nitrogen) flow rate: 3.0mL / min;

[0073] Split ratio: 20:1;

[0074] Injection volume: 1μL

[0075] Oven heating program:

[0076] Heating rate (℃ / min) temperature (°C) Hold time (min) / 100 0 8 120 5

[0077] Experimental procedure

[0078] Take an appropriate amount of 1,2-dibromoethane, dissolve it in a solvent, and prepare a reference solution containing 0.0005 mg of 1,2-dibromoethane per 1 mL; take another 100 mg of loratadine ring compound, add 1.0 mL reference substance solution, prepared into a system suitability solution containing 100 mg of loratadine ring compound per 1 mL. Take the system suitability ...

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Abstract

The invention belongs to the field of analytical chemistry, and discloses a method for separating and detecting a genotoxic substance 1, 2-dibromoethane in a loratadine ring compound serving as a loratadine starting material by using gas chromatography. According to the method, a 6% cyanopropyl-94% dimethyl polysiloxane capillary chromatographic column and an electron capture detector are adopted.According to the method, the content of the genotoxic substance 1, 2-dibromoethane in the loratadine ring compound can be quantitatively determined, so that the 1, 2-dibromoethane in the loratadine ring compound is effectively controlled, and the quality of the loratadine ring compound is controllable. The method disclosed by the invention is strong in specificity, high in accuracy, good in durability and simple and rapid to operate.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a method for separating and measuring genotoxic substance 1,2-dibromoethane in loratadine cyclic compound, a starting material of loratadine, by gas chromatography. Background technique [0002] Loratadine is an H1 receptor blocker with high selectivity for peripheral H1 receptors and weak affinity for central H1 receptors. It can inhibit the release of leukotrienes and histamine from mast cells. It is a second-generation long-acting drug. Tricyclic antihistamines, the zwitterionic feature in the molecular structure of loratadine makes it have no obvious central inhibitory effect, and is mainly used clinically for the prevention and treatment of allergic rhinitis, chronic idiopathic urticaria, allergic asthma and specific Dermatitis and other diseases. The chemical name of loratadine is 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1- ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/30G01N30/70G01N30/60
CPCG01N30/02G01N30/06G01N30/30G01N30/60G01N30/70
Inventor 张力娜刘秋叶王宇杰
Owner BEIJING VENTUREPHARM BIOTECH
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